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Clinical Trial Summary

Patients with diabetes at high risk of ulceration require a perfect fitting shoe to avoid high shear and pressure forces. Neuropathy skews sensory perceptions and can alter the proper selection of the therapeutic footwear. The aims of study were to evaluate the ability of high-risk patients with diabetes in remission to select the proper therapeutic footwear and to validate a novel 3D foot scanner app for selecting the proper fitting therapeutic footwear.


Clinical Trial Description

A Randomized Controlled Clinical Trial in 30 patients with a previous healed diabetic foot ulcer. After parallel randomization (1:1) patients will be enrolled into two different groups: 1. Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences; 2. Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). Validation of proper therapeutic footwear fitting will be performed by a specialized podiatrist after acquisition of shoes in both groups. Therapeutic Footwear will be recommended to change when following ill fitting reason been found: excessive length or tight, or compromise with toes ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05353114
Study type Interventional
Source Universidad Complutense de Madrid
Contact
Status Completed
Phase N/A
Start date June 15, 2022
Completion date July 15, 2022

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